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Clinical Trials and Private Health Insurance Reimbursement

The National Coverage Decision of 2000 outlines the Centers for Medicare and Medicaid's (CMS) policy for reimbursement of services for Medicare beneficiaries enrolled in clinical trials. Several states, including New Jersey and Connecticut, have special agreements or legislation regarding reimbursement from private health insurers. These policies address coverage of services or benefits and the types of clinical trials that qualify for coverage.

In addition, there are key criteria that further define coverage. These include

1.  the need for patients to be enrolled in clinical trials of therapeutic intent
2.  the unavailability of other medical treatment
3.  the restriction of coverage to a particular clinical trial phase

As expected, pre-authorization is usually necessary for many services and, in some cases, insurance reimbursement may be limited to a set amount per annum. Some insurers will consider insurance coverage on a case-by-case basis.

Stephanie Wasserman, of the National Conference of State Legislatures, reports that New York State is not one of the states that currently mandate private payers to cover services for patients enrolled in clinical trials. While health plans in New York may cover clinical trial services, it is on a case-by-case basis. Each patient enrolled in a clinical trial should check with his/her insurer to guarantee clinical trial coverage and to ascertain what services (a) are covered and (b) require pre-authorization.

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